Terumo Neuro · 7 hours ago
Sr Associate, Field Clinical Monitoring (U.S. Remote)
United States
Full-time
Remote
Senior Level
$111K/yr - $139K/yr
6+ years expTerumo Neuro is a company focused on driving study execution and operational excellence in clinical research. The Sr Associate, Field Clinical Monitoring will be responsible for ensuring compliance with study protocols and FDA regulations while overseeing site operations and communication among key stakeholders.
Medical Device
Responsibilities
Identify, develop, and maintain investigators and sites capable of delivering start-up goals, enrollment targets, and required data quality
Facilitate and maintain open communication among investigational sites, study and data management teams, and the company. Ensure effective communication with key stakeholders
Ensure clinical studies are conducted in accordance with the protocol, GCP, company SOPs, and all applicable regulations (e.g., FDA)
Understand, read, prepare, and deploy study documentation including, informed consents, study forms, and study training documents
Responsible for collecting and reviewing essential documents, facilitating necessary corrections, and filing in assigned system(s)
Maintain device accountability records
Review data and source documentation from investigational sites for accuracy and completeness; facilitate resolution of data queries and manage action items to completion
Conduct and perform site initiation visits, site training, interim monitoring visits, and close-out visits
Maintain accurate, detailed, and complete records of monitoring visits and reporting findings according to plans and processes
Collaborate with sites to ensure adherence to compliance requirements and escalates non-compliance when necessary
Draft study-specific Monitoring Plans in collaboration with a Project Manager and Clinical Quality Assurance
Assume Lead Clinical Research Associate responsibilities on assigned studies including reporting of monitoring KPIs
Serve as a mentor to more junior Field Monitors
Comply with applicable Laws and Regulations, adhere to Quality Management System processes and requirements as well as demonstrate Ethics and Integrity in all matters and at all levels throughout the organization
Perform additional duties as assigned
Qualification
Required
Bachelor's degree in a related field of study, preferably in Life Science, or equivalent combination of education and experience
Minimum six (6) years of medical device monitoring experience
Minimum four (4) years of neurovascular experience
Ability to travel M-F, 4 weeks a month (75%-100%)
Strong knowledge of FDA regulations for clinical trials and clinical procedures
Strong collaborative skills with demonstrated ability to work with physicians, site coordinators, and others within the company
Experience using technologies for clinical research (electronic data capture and clinical trial management systems)
Excellent written and verbal communication skills, including computer literacy
Strong computer skills including MS Office (e.g., Word, Excel, Access, PowerPoint, Outlook, Teams, etc.)
Preferred
Proven clinical research expertise in various therapeutic areas
Experience in a catheter lab environment
Company
Terumo Neuro
We’re in business to create and deliver innovations that redefine what’s possible in neurovascular treatment, meaningfully advancing both physician practice and patient outcomes.
1001-5000 employees
Funding
Current Stage
Late StageCompany data provided by crunchbase